SUMMARY

TrialScope Disclose includes a set of standard assessment and due date rules that can be enabled/disabled which help customers comply with their obligation to disclose clinical trial information.

For GRLS (Russia), TrialScope Disclose includes the following rules:

Assess if CTA Registration is needed on GRLS (Russia)

Automatically assess CTA submission is required for DRKS for interventional trials conducted in Russia that have started on or after November 1, 2010.

Interventional trials with a site in Russia that have started since Nov 1, 2010, require an approved clinical trial application that is submitted to the authorities before the enrollment start.

NOTE: For CTA submissions there is no regulatory due date, except that approval is required to conduct a trial. The system assumes the CTA should be submitted 30 days before study start, but there is likely an applicable company policy.

Initial CTA Law Due Date on GRLS (Russia)

GRLS (Russia) CTA Submission is assessed, disclosure needs to be posted on GRLS 30 days prior to study start date.

Compliance Law Due date is 30 days prior to Study Start Date.